Associate Director, Global R&D Compliance Lead

Galderma•Boston, MA

2d•Onsite

About The Position

The Global R&D Compliance Lead is responsible for leading and managing compliance support to Galderma’s global R&D organization, advising on compliance matters and key risk areas within R&D. Serving as the global point contact on all compliance matters to, among others, the Global Head of R&D and Global Head of Medical Affairs, the role will work closely with R&D management as well as members of Galderma’s R&D Legal group (and more broadly Galderma’s Legal & Compliance function). Reporting to the Global Head of Ethics & Compliance, the role will be based in Galderma’s R&D hub in Boston.

Requirements

Bachelor’s Degree required; lawyer qualification strongly preferred.
7+ years of experience advising a pharmaceutical, biotechnology or medical device company on compliance matters required, with 3 years of in-house experience preferred.
Strong understanding of healthcare compliance and broader legal and regulatory framework laws, including regulations and guidance applicable to the pharmaceutical and medical device industries.
Significant experience advising R&D organization(s) on R&D and related matters.
Expertise and significant experience advising on U.S. and international healthcare compliance for prescription products and devices, including specifically in respect of R&D activities.
Deep knowledge of pharmaceutical industry regulations and therapeutic areas, and of the laws, regulations, and industry guidance relevant to the commercialization of pharmaceutical products (including but not limited to the U.S. Federal Anti-Kickback Statute, False Claims Act, Food Drug and Cosmetic Act, OIG and DOJ Guidelines, PhRMA Code, and U.S. state and local marketing compliance laws and relevant government enforcement actions).
Experience developing, designing, and implementing compliance training programs, developing risk management strategies, and drafting policies and standard operating procedures.
Proven track record of developing, building, and implementing effective compliance programs.
Strong and proven strategic leadership skills, with executive presence and gravitas.
Ability to identify and drive improvement and new initiatives throughout the organization.
Energetic leader with passion for growing a business.
Solution-oriented, flexible, and agile with the ability to move quickly, pivot when needed, manage multiple priorities, and meet deadlines in a fast-paced work environment.
Cultural sensitivity and demonstrated success in navigating a large and matrixed global organization.
Excellent verbal and written communication skills, including outstanding presentation skills, with the ability to deliver clear and concise guidance and instructions.
Excellent qualitative and quantitative analytical skills to identify and solve a wide range of business problems.
Ability to interact and partner effectively with senior management and associates at all levels within the organization.
Ability to implement effective compliance programs alongside business objectives.
Strong attention to detail and strong organizational skills.
Ability to effectively manage conflict and other challenging situations.
Reputation for the highest integrity and ethical standards.

Responsibilities

Serves as the primary compliance point of contact for the R&D organization (including Global Medical Affairs).
Oversees Galderma’s compliance program relevant to R&D matters, ensuring alignment with regulator expectations and Galderma’s own compliance program, relevant codes of practice and relevant country laws and regulations.
Serves on, and as the primary compliance contact for, the Global Funding Review Committee (GFRC)
Manages Galderma’s research and consultancy arrangements, in particular with those healthcare practitioners (HCPs) serving as Key Opinion Leaders (KOLs) ensuring visibility and oversight of Galderma’ global and in-market spend for such KOLs
Ensures compensation and other remuneration provided to HCPs, HCOs, and other covered persons/entities under arrangements are appropriately captured and routed to Galderma’s financial transparency processes and systems
Manages and serves as the primary interface for Galderma’s FMV processes and specific rates
Supports and advises on internal governance related to the review and approval of Investigator Initiated Studies (IIS), clinical trial activities and research funding requests
Leads and co-ordinates the training of global R&D personnel on R&D-specific compliance policies and procedures
Leads and co-ordinates R&D risk & monitoring activities, and related remediation
Supports and advises on internal governance related to the review and approval of congress and meeting activities
Monitors the regulatory and broader compliance environment to determine the potential impact of regulatory changes on compliance programs as they affect R&D and drive necessary changes to relevant compliance policies and processes.